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BioCentury - Volume of Comments Delays Foundation Coverage Decision

March 2, 2018

Author:

Erin McCallister

After missing the Feb. 28 decision date, the Centers for Medicare & Medicaid Services (CMS) said it will "soon" issue a final National Coverage Determination (NCD) for next-generation sequencing (NGS) cancer diagnostics, including FoundationOne CDx from Foundation Medicine Inc. (NASDAQ:FMI).

FoundationOne was granted a proposed NCD on Nov. 30, 2017, simultaneous with its FDA approval as a universal companion diagnostic for FDA-approved targeted cancer agents. The in vitro test had undergone parallel review by CMS and FDA.

CMS said it delayed the final NCD because it needs more time to review the 315 public comments it received on the proposed NCD. An NCD outlines the criteria under which Medicare providers must cover a test or treatment.

It also includes coverage with evidence development (CED) for laboratory-developed tests (LDTs) using NGS that have received 510(k) clearance. Under CED, CMS will cover tests as long as certain criteria are met to gather data in support of the LDTs' clinical utility through clinical trials or patient registries.

Several of the comments opposing the NCD say it is too restrictive because it excludes LDTs that are not FDA-approved. The comments come from academic centers which have their own LDTs to diagnose and design treatment programs for cancer patients.

Patient groups including Friends of Cancer Research supported the NCD's intent but also said that the NCD and CED requirements could stifle innovation at these centers. "Academic centers are the most common developers of LDTs and often serve to drive innovation in diagnostic tests," wrote Friends President and CEO Jeffrey Allen. Friends also noted that the CED requirements to include only trials registered with NCI's National Clinical Trials Network (NCTN) could affect patients negatively. "NGS tests are used to identify patients for both publicly and privately funded trials. Excluding coverage in non-NCTN [studies] could impact patient access to clinical trials," Allen wrote.

Goswami Joydeep, who is Thermo Fisher's president of clinical NGS and oncology, also noted that the NCD could eliminate Medicare coverage of some necessary LDTs in cancer indications where NGS tests are not yet FDA-approved. Joydeep suggested that CMS consider a tiered coverage model.

In his comments, Foundation CMO Vincent Miller also noted that the CED requirements should be implemented in a way that does not add undue burden to patients.